Six "firsts" in electroceutical approvals of 2019
Jul 05, 2019 Dr Nadia Tsao
IDTechEx has been following the field of bioelectronic medicine over the past year and have identified several fast-growing areas, including peripheral nerve stimulation, which is forecast to grow at 35% CARG for 2019 - 2029. Several firsts in regulatory approvals and clearances of bioelectronic medicine devices over the first half of 2019 mark important initial steps in growing the market and increasing the number of patients being treated by these technologies. Please refer to the IDTechEx market research report Bioelectronic Medicine 2019-2029 for more information.
Bioelectronic medicine refers to devices that use electrical stimulation to treat health conditions. The most common of these devices is the pacemaker, but there are others being used to treat movement disorders, chronic pain, and even epilepsy. IDTechEx have previously reported that treatment of chronic diseases will be key to the forecasted $60 billion market. The recent regulatory approvals, particularly in devices that stimulate nerves in the peripheral nervous system, attest to this conclusion. In this article, IDTechEx highlights some innovative therapies approved in the first half of 2019.
January 2019: Kicking off the streak in 2019 was Tivic Health, which received FDA clearance of the ClearUP. The ClearUP is a portable, drug-free device that is the first bioelectronic treatment for sinus pain from allergies. The device targets the facial nerves for pain relief.
February 2019: Bioness received CE mark for their StimRouter device. The StimRouter is a minimally invasive device that targets the tibial nerve for the treatment of overactive bladder. Alternatives to this technology include invasive bioelectronic devices, or frequent trips to a clinician's office.
March 2019: Nyxoah received CE mark for the Genio implant for the treatment of obstructive sleep apnea (OSA). Stimulation of the hypoglossal nerve by the device moves the tongue to clear the airway and thus removing the obstruction.
April 2019: NeuroSigma received FDA clearance of Monarch for the treatment attention deficit hyperactivity disorder (ADHD). It targets the trigeminal nerve and has been shown to increase activity in brain regions responsible for attention, emotion and behaviour. This is the first device to be cleared for the treatment of ADHD.
May 2019: Theranica received de novo FDA clearance for the Nerivio Migra, a bioelectronic device for the treatment of migraine headaches. Unlike other bioelectronic devices used to treat migraine headaches, this device is worn on the upper arm rather than on the head.
June 2019: Innovative Health Solutions received FDA clearance for the IB-stim. The IB-stim is the first device cleared for the treatment of irritable bowel syndrome. The device is worn on the ear and stimulates cranial nerve bundles to target areas of the brain involved in processing pain.
As evidenced by this list, companies developing bioelectronic medicine targeting the peripheral nervous system are making great strides towards commercial success. The use of electroceuticals, rather than pharmaceuticals, to treat patients is a rising trend as seen already with the uptake of spinal cord stimulators for the treatment of chronic pain. Electroceuticals provide a more local, targeted and immediate treatment than that provided by traditional pharmaceuticals. Commercial uptake of disruptive technologies such as those listed in this article will be key to driving the future of bioelectronic medicine.
To learn more about the topic, and the subset of bioelectronic medicine that restores lost senses, please refer to the reports Bioelectronic Medicine 2019-2029 and Neuroprosthetics 2018-2028: Technologies, Forecasts, Players.
Top image: Nyxoah